Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

The External Partners Delivering The Components Of RNA Therapies

“RNA-based therapeutics” is now a diverse and wide field of application; outsourcing the components of these programs is challenging. Executives at the Society For RNA Therapeutics (SRT) say assembling an entire supply chain can soak up time and resources. Which partners to select depends on what area of RNA development you are pursuing. A fundamental task before all RNA sponsors is thinking deeply in terms of assembling development and manufacturing ecosystems, starting at the earliest stages of research and company formation.

GUEST COLUMNISTS

FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
The Unspoken Truth About Cell Therapy Product Understanding
Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.
Implementing And Optimizing Your eQMS
This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.
CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

PHARMA OUTSOURCING WHITE PAPERS

Why Get Cleaning Validation Support From The Cleaner Supplier?
Standardize compliant cleaning by integrating risk-based validation, effective residue detection, and science-based limits to reduce cross-contamination and protect product quality.

Redefining Value In Biologics Outsourcing Partnerships
Biologics outsourcing is shifting to strategic partnerships focused on modality expertise, regulatory excellence, and integrated end-to-end capabilities.
Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies
Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.
USP <665> Becomes Official On May 1, 2026. Are You Ready?
With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.
Aseptic Process Design And Simulation Under Annex 1 Guidelines
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
From Process Monitoring To Manufacturing Intelligence: Real-Time Analytics And Predictive Control In Biomanufacturing
Advanced analytics, predictive modeling, explainable AI, and digital twins are helping biomanufacturers improve process visibility, anticipate outcomes, and support smarter operational decisions.